The present invention relates to filling machines.
Automated fill systems and filling machines are used for transferring fluids from a reservoir to containers. Typically, these automated systems incorporate a flow meter to accurately control the amount of fluid introduced into each container, either by mass (weight) or volume. These systems are typically used in the pharmaceutical, biopharmaceutical, chemical, and food packaging industries. The automated systems also generally include a stop valve controlled by the flow meter and a nozzle used to transfer the measured amount of fluid to a container.
In many industries, such as pharmaceutical and biopharmaceutical, it is important to clean, sterilize, and validate permanent (i.e., non-disposable process piping) conduits within the system to prevent cross-contamination when the fluid reservoir is changed to introduce a different fluid through the system. This is referred to in the industry as changing batches. When changing batches, it is common to inject cleaning chemicals, pure water, and steam through the conduits to clean and sterilize them. Conduit portions may also have to be disassembled for cleaning and sterilization. The cleaning and sterilizing must also be validated or certified as sufficiently aseptic prior to proceeding with the next batch. This results in a process that is time consuming, labor intensive and costly due to the associated downtime of the system.
Often, systems and filling machines have added additional valves and fittings at multiple locations along the conduits of the system to facilitate a clean-in-place (CIP) or steam-in-place (SIP) process, and to allow cleaning and validation over smaller sections of the system. For example, if the entire system cannot be validated, the contamination can be isolated to a specific section and then only that specific section can be re-cleaned. In other words, isolation valves allow one or more sections of the flow path to be cut off to allow for further cleaning of only the flow path sections that require cleaning. Although this arrangement simplifies cleaning, sterilizing, and validating between batches, it does not eliminate the costly, labor intensive, and time consuming cleaning process with respect to the flow meter and other process piping of the filling machine.
In addition, it is often desirable to sterilize the container and the fluid after the fluid has been placed into the container. Sterilizing the fluid and container after the fluid is placed into the container is known as terminal sterilization. Autoclaving is one method of terminal sterilization. Autoclaving typically includes the use of pressurized steam to sterilize the container and fluid. However, biopharmaceuticals are typically not suited for such terminal autoclaving because the pressurized steam, which is often superheated, can destroy living organisms in the biopharmaceutical solution. Therefore, manual methods for terminal sterilization have been developed. Such methods are labor intensive, time consuming, and costly.